TAMIFLU Drug Patent Profile
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Which patents cover Tamiflu, and when can generic versions of Tamiflu launch?
Tamiflu is a drug marketed by Roche and is included in two NDAs.
The generic ingredient in TAMIFLU is oseltamivir phosphate. Thirty-six suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tamiflu
A generic version of TAMIFLU was approved as oseltamivir phosphate by NATCO on August 3rd, 2016.
Paragraph IV (Patent) Challenges for TAMIFLU
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TAMIFLU | for Oral Suspension | oseltamivir phosphate | 6 mg/mL | 021246 | 1 | 2015-06-18 |
| TAMIFLU | Capsules | oseltamivir phosphate | 30 mg and 45 mg | 021087 | 1 | 2011-08-02 |
| TAMIFLU | Capsules | oseltamivir phosphate | 75 mg | 021087 | 1 | 2010-11-15 |
US Patents and Regulatory Information for TAMIFLU
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-003 | Jul 2, 2007 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-002 | Mar 21, 2011 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TAMIFLU
See the table below for patents covering TAMIFLU around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 191711 | ⤷ Start Trial | |
| Austria | 305453 | ⤷ Start Trial | |
| Australia | 5357196 | ⤷ Start Trial | |
| Australia | 720933 | ⤷ Start Trial | |
| Brazil | 9607098 | COMPOSTO E COMPOSIÇÃO FARMACÊUTICA. | ⤷ Start Trial |
| Canada | 2188835 | NOUVEAUX INHIBITEURS SELECTIFS DE NEURAMINIDASES VIRALES OU BACTERIENNES (NOVEL COMPOUNDS AND METHODS FOR SYNTHESIS AND THERAPY) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAMIFLU
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0759917 | CA 2002 00027 | Denmark | ⤷ Start Trial | |
| 0759917 | 0290024-9 | Sweden | ⤷ Start Trial | |
| 0759917 | 90991 | Luxembourg | ⤷ Start Trial | |
| 0759917 | SPC031/2002 | Ireland | ⤷ Start Trial | SPC031/2002: 20021107, EXPIRES: 20160226 |
| 0759917 | 38/2002 | Austria | ⤷ Start Trial | PRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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